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Acquisition of clinical data and investigation for the development of artificial intelligence (AI) in the diagnosis of subepithelial lesion -prospective cohort study-

Acquisition of clinical data and investigation for the development of artificial intelligence (AI) in the diagnosis of subepithelial lesion -prospective cohort study- - Development study of subepithelial lesion (SEL) - artificial intelligence (AI)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000050718
Enrollment
720
Registered
2023-06-30
Start date
2023-05-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suspected upper gastrointestinal subepithelial lesion

Interventions

None listed

Sponsors

Nagoya University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients undergoing upper gastrointestinal EUS examination for the purpose of detailed examination, tissue sampling, and follow-up for suspected SEL lesions (2) Age at the time of consent acquisition is 18 years or older. (3) Patients who have given their voluntary written consent after receiving sufficient explanation about participating in this study, and with sufficient understanding.

Exclusion criteria

Exclusion criteria: (1) Patients who are judged by the principal investigator to be inappropriate as research subjects (2) Patients who are incapable of consent

Design outcomes

Primary

MeasureTime frame
Accuracy in the three categories of SEL differentiation (GIST, leiomyoma, other SELs) on EUS videos in the AI diagnostic system and expert endoscopists

Secondary

MeasureTime frame
Diagnostic performance (sensitivity, specificity, positive predictive value, negative predictive value, accuracy) of the AI diagnostic system and expert endoscopists in the two SEL categories (GIST, others) Diagnostic performance in multi-category classification (accuracy, sensitivity per category) Diagnostic performance of non-expert endoscopists, diagnostic performance of various tissue biopsies, and EUS findings that contribute to diagnosis

Countries

Japan

Contacts

Public ContactKeiko Hirai

Nagoya University Graduate School of Medicine Department of Gastroenterology and Hepatology

hiraik53@med.nagoya-u.ac.jp0527412172

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026